🇪🇺 Elexacaftor, Tezacaftor, Ivacaftor in European Union

EMA authorised Elexacaftor, Tezacaftor, Ivacaftor on 21 August 2020

Marketing authorisation

EMA — authorised 21 August 2020

  • Application: EMEA/H/C/005269
  • Marketing authorisation holder: Vertex Pharmaceuticals (Ireland) Limited
  • Local brand name: Kaftrio
  • Indication: Kaftrio tablets are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Kaftrio granules are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
  • Pathway: orphan
  • Status: approved

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Elexacaftor, Tezacaftor, Ivacaftor in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Elexacaftor, Tezacaftor, Ivacaftor approved in European Union?

Yes. EMA authorised it on 21 August 2020.

Who is the marketing authorisation holder for Elexacaftor, Tezacaftor, Ivacaftor in European Union?

Vertex Pharmaceuticals (Ireland) Limited holds the EU marketing authorisation.